Many HIV patients stay on first line longer - TASO study

 

HIV/AIDS investigators from three institutions have found that over 80% patients living with HIV were able to stay on first line for a long time, meaning they were adhering to their antiretroviral (ARV) treatment very well. It I estimated that 1.5 million Ugandans are living with HIV, out of which 700,000 are accessing ARVs.

 

The study, which was conducted by The AIDS Support Organization (TASO) in partnership with Uganda Virus Research Institute/ Medical Research Centre (UVRI/UMR) and University of the British Colombia- Canada at TASO clinic in Jinja between January 1, 2004 and March 31, 2014, also indicated that second line treatment was found to be well tolerated.

 

The three principal investigators for this study were Dr. Josephine Birungi, a research manager at TASO, Professor Pontiano Kaleebu, the acting director of UVRI, and Dr. David Moore from the University of British Colombia- Canada.

 

Dr. Birungi said the epidemic has matured over 30 years and since we started ART in Uganda on large scale in 2004, there was a need to look at these patients who have been on ART for a long time. The first ever study in Uganda codenamed the "Long Term Outcomes on Antiretroviral Therapy (ART) was disseminated last Friday at TASO- Kanyanya and it looked at HIV positive patients who have been on ART for at least four years.

 

"A lot may be known for patients who have just started ART, but there are patients who have been on ART for a long time, 10 years or more. Since we started the ART program in Uganda in 2004, we wanted to know how these patients are doing on adherence, whether their viral load  is low or has increased and if they have developed drug resistance," said Birungi.

 

Viral load is the term used to describe the amount of HIV in one's blood. The more HIV there is in your blood (and therefore the higher your viral load), then the faster your CD4 cell count will fall, and the greater your risk of becoming ill because of HIV.

 

Non-adherence increases the risk of viral mutations, which can result in cross-resistance to other medications or transmission of multi resistant virus strains, and thus the risk for initial therapy failure in subsequently infected individuals.

 

One of the biggest challenges for people living with HIV/AIDS is taking medication every day. The drugs weaken the body because they are strong and if your immunity is already weak, you can easily give up medication.

 

The study had four objectives. One, to know the prevalence of virological failure-how many people living with HIV had a high viral load. But the study found that many had a low viral load which was good. Another was to find out if counseling was effective if it is done to someone who has been on ART for a long time. The investigator found out that counseling was not as effective as they thought.

 

The third objective was to know if one is on the first line, for how long he can stay on that line, and the study found that people stay on the first line for a long time. Among those who were on the first line only 3% crossed over to the second line, meaning that they were adhering well to treatment. The fourth objective was to find how people on the second line were fairing, and investigators found that they were doing well on the second line.

 

A total of  1091 HIV positive people were recruited into the study and monitored for three years to see among them how many had greater than 1000 copies/ml, meaning they were failing and how many had less than 1000 copies/ml, meaning they were  doing well on treatment.

 

Only about 7% of the 7.5% were failing. The Ministry of Health guidelines say that if you do a viral load and find someone with a first high viral load, don't change them immediately or do not label them failures immediately. First counsel them they could be having a problem with adhering may be they are not swallowing their pills well, the reason the virus is not being suppressed.

 

During the study, those people who were failing were counseled for three months. Of the 1091 patients that were screened, 113 (10.3%) had viral load less than 1000 copies/ml of whom 97(86%) were eventually switched to second line. The study showed that there was no observed increase in reported symptoms after switch. In particular, there was no change in reports of diarrhea, a commonly reported side effect of lopinavir and ritonavir.

 

The desire of the Ministry of health is that many people keep on the first line because it is cheaper and easier. But as long as your viral load stays higher you will be switched to the second line. High viral load is therefore an indicator for failure. So long as the pills are not working, you are not taking your pills well, not adhering to your medication, your viral load will always go high.

 

Birungi says adherence is imperative to guarantee the effectiveness of ART which has led to a substantial reduction in HIV-associated morbidity and mortality and HIV infection has entered the stage of chronic disease management. Lasting suppression of viral replication is the goal of ART and one of the most important factors influencing long-term prognosis of HIV infection.

 

Yet adherence is one of the most crucial issues in the clinical management of HIV-infected patients receiving antiretroviral therapy (ART), and is imperative to guarantee the effectiveness of ART.Non-adherence increases the risk of viral mutations, which can result in cross-resistance to other medications or transmission of multi-resistant virus strains, and thus the risk for initial therapy failure in subsequently infected individuals.

 

ARVs attack the virus directly and stop it from multiplying in the body. When you take medicine your immune system improves. But when you do not adhere well, especially if the adherence is very poor, your immune system can go back under 100 cells, which health workers call treatment failure.

 

The key consequence of none adherence, according to Birungi, is the virus becomes resistant to the drugs. You take the medicine but the virus continues to multiply, which is drug resistance. Also when they change the medicine to the second line and you don't adhere the second line also becomes resistant. Drug resistance makes the immune system to start falling again.

 

When there is virological failure, the virus multiplies and that virus destroys your immune system and you get what we call immunological failure and you start getting opportunistic infections.

 

 

Investigators conducted a retrospective cohort analysis of all patients less than 18 years who initiated ART at TASO -Jinja between January 1, 2004 and July 31, 2009.

 

They identified all clients in community and facility-based ART delivery arms using an electronic clinical monitoring database. The catchment area included participants in villages up to 75 kilometers away from Jinja town.

 

Enrollees were expected to attend regular clinic or outreach visits every one-to three months. CD 4 cell count testing was offered every six months. .